Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris

Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials

Angela Moore, Lawrence J. Green, Suzanne Bruce, Neil Sadick, Eduardo Tschen, Philip Werschler, Fran E. Cook-Bolden, Sunil S. Dhawan, Douglass Forsha, Michael H. Gold, Scott Guenthner, Steven E. Kempers, Leon H. Kircik, Jennifer L. Parish, Marta I. Rendon, Phoebe Rich, Linda Stein-Gold, Stephen K. Tyring, Robert A. Weiss, Adnan Nasir & 4 others Carsten Schmitz, Terry I. Boodhoo, Alexandre Kaoukhov, David R. Berk

Research output: Contribution to journalArticle

6 Citations (Scopus)

Abstract

BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

Original languageEnglish (US)
Pages (from-to)987-996
Number of pages10
JournalJournal of drugs in dermatology : JDD
Volume17
Issue number9
StatePublished - Sep 1 2018

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Acne Vulgaris
Placebos
Clinical Trials
Nasopharyngitis
Tetracycline
Anti-Bacterial Agents
Headache
Vulvovaginal Candidiasis
Research Personnel
Sunburn
Tinnitus
Vertigo
Dizziness
Nausea
Vomiting
Safety
Infection
Pharmaceutical Preparations

ASJC Scopus subject areas

  • Dermatology

Cite this

Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris : Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. / Moore, Angela; Green, Lawrence J.; Bruce, Suzanne; Sadick, Neil; Tschen, Eduardo; Werschler, Philip; Cook-Bolden, Fran E.; Dhawan, Sunil S.; Forsha, Douglass; Gold, Michael H.; Guenthner, Scott; Kempers, Steven E.; Kircik, Leon H.; Parish, Jennifer L.; Rendon, Marta I.; Rich, Phoebe; Stein-Gold, Linda; Tyring, Stephen K.; Weiss, Robert A.; Nasir, Adnan; Schmitz, Carsten; Boodhoo, Terry I.; Kaoukhov, Alexandre; Berk, David R.

In: Journal of drugs in dermatology : JDD, Vol. 17, No. 9, 01.09.2018, p. 987-996.

Research output: Contribution to journalArticle

Moore, A, Green, LJ, Bruce, S, Sadick, N, Tschen, E, Werschler, P, Cook-Bolden, FE, Dhawan, SS, Forsha, D, Gold, MH, Guenthner, S, Kempers, SE, Kircik, LH, Parish, JL, Rendon, MI, Rich, P, Stein-Gold, L, Tyring, SK, Weiss, RA, Nasir, A, Schmitz, C, Boodhoo, TI, Kaoukhov, A & Berk, DR 2018, 'Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris: Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials', Journal of drugs in dermatology : JDD, vol. 17, no. 9, pp. 987-996.
Moore, Angela ; Green, Lawrence J. ; Bruce, Suzanne ; Sadick, Neil ; Tschen, Eduardo ; Werschler, Philip ; Cook-Bolden, Fran E. ; Dhawan, Sunil S. ; Forsha, Douglass ; Gold, Michael H. ; Guenthner, Scott ; Kempers, Steven E. ; Kircik, Leon H. ; Parish, Jennifer L. ; Rendon, Marta I. ; Rich, Phoebe ; Stein-Gold, Linda ; Tyring, Stephen K. ; Weiss, Robert A. ; Nasir, Adnan ; Schmitz, Carsten ; Boodhoo, Terry I. ; Kaoukhov, Alexandre ; Berk, David R. / Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris : Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials. In: Journal of drugs in dermatology : JDD. 2018 ; Vol. 17, No. 9. pp. 987-996.
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abstract = "BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9{\%} and 22.6{\%} (sarecycline), respectively, versus 10.5{\%} and 15.3{\%} (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8{\%} and -49.9{\%} (sarecycline), respectively, versus -35.1{\%} and -35.4{\%} (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2{\%} of either sarecycline or placebo group) were nausea (4.6{\%} [sarecycline]; 2.5{\%} [placebo]), nasopharyngitis (3.1{\%}; 1.7{\%}), headache (2.7{\%}; 2.7{\%}), and vomiting (2.1{\%}; 1.4{\%}) and, in SC1402, nasopharyngitis (2.5{\%}; 2.9{\%}) and headache (2.9{\%}; 4.9{\%}). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1{\%} of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1{\%} [sarecycline] and 0 [placebo]; SC1402: 0.3{\%} and 0) and mycotic infection (0.7{\%} and 0; 1.0{\%} and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.",
author = "Angela Moore and Green, {Lawrence J.} and Suzanne Bruce and Neil Sadick and Eduardo Tschen and Philip Werschler and Cook-Bolden, {Fran E.} and Dhawan, {Sunil S.} and Douglass Forsha and Gold, {Michael H.} and Scott Guenthner and Kempers, {Steven E.} and Kircik, {Leon H.} and Parish, {Jennifer L.} and Rendon, {Marta I.} and Phoebe Rich and Linda Stein-Gold and Tyring, {Stephen K.} and Weiss, {Robert A.} and Adnan Nasir and Carsten Schmitz and Boodhoo, {Terry I.} and Alexandre Kaoukhov and Berk, {David R.}",
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language = "English (US)",
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TY - JOUR

T1 - Once-Daily Oral Sarecycline 1.5 mg/kg/day Is Effective for Moderate to Severe Acne Vulgaris

T2 - Results from Two Identically Designed, Phase 3, Randomized, Double-Blind Clinical Trials

AU - Moore, Angela

AU - Green, Lawrence J.

AU - Bruce, Suzanne

AU - Sadick, Neil

AU - Tschen, Eduardo

AU - Werschler, Philip

AU - Cook-Bolden, Fran E.

AU - Dhawan, Sunil S.

AU - Forsha, Douglass

AU - Gold, Michael H.

AU - Guenthner, Scott

AU - Kempers, Steven E.

AU - Kircik, Leon H.

AU - Parish, Jennifer L.

AU - Rendon, Marta I.

AU - Rich, Phoebe

AU - Stein-Gold, Linda

AU - Tyring, Stephen K.

AU - Weiss, Robert A.

AU - Nasir, Adnan

AU - Schmitz, Carsten

AU - Boodhoo, Terry I.

AU - Kaoukhov, Alexandre

AU - Berk, David R.

PY - 2018/9/1

Y1 - 2018/9/1

N2 - BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

AB - BACKGROUND: Side effects may limit the use of current tetracycline-class antibiotics for acne. OBJECTIVE: Evaluate the efficacy and safety of once-daily sarecycline, a novel, narrow-spectrum tetracycline-class antibiotic, in moderate to severe acne. METHODS: Patients 9-45 years with moderate to severe facial acne (Investigator's Global Assessment [IGA] score ≥ 3, 20-50 inflammatory and ≤ 100 noninflammatory lesions, and ≤ 2 nodules) were randomized 1:1 to sarecycline 1.5 mg/kg/day or placebo for 12 weeks in identically designed phase 3 studies (SC1401 and SC1402). RESULTS: In SC1401 (sarecycline n=483, placebo n=485) and SC1402 (sarecycline n=519, placebo n=515), at week 12, IGA success (≥ 2-grade improvement and score 0 [clear] or 1 [almost clear]) rates were 21.9% and 22.6% (sarecycline), respectively, versus 10.5% and 15.3% (placebo; P less than 0.0001 and P equals 0.0038). Onset of efficacy in inflammatory lesions occurred by the first visit (week 3), with mean percentage reduction in inflammatory lesions at week 12 in SC1401 and SC1402 of -51.8% and -49.9% (sarecycline), respectively, versus -35.1% and -35.4% (placebo; P less than 0.0001). Onset of efficacy for absolute reduction of noninflammatory lesion count occurred at week 6 in SC1401 (P less than 0.05) and week 9 in SC1402 (P less than 0.01). In SC1401, the most common TEAEs (in ≥ 2% of either sarecycline or placebo group) were nausea (4.6% [sarecycline]; 2.5% [placebo]), nasopharyngitis (3.1%; 1.7%), headache (2.7%; 2.7%), and vomiting (2.1%; 1.4%) and, in SC1402, nasopharyngitis (2.5%; 2.9%) and headache (2.9%; 4.9%). Most were not considered treatment-related. Vestibular (dizziness, tinnitus, vertigo) and phototoxic (sunburn, photosensitivity) TEAEs both occurred in ≤ 1% of sarecycline patients. Gastrointestinal TEAE rates for sarecycline were low. Among females, vulvovaginal candidiasis (SC1401: 1.1% [sarecycline] and 0 [placebo]; SC1402: 0.3% and 0) and mycotic infection (0.7% and 0; 1.0% and 0) rates were low. CONCLUSION: The narrow-spectrum antibiotic sarecycline was safe, well tolerated, and effective for moderate to severe acne, with low rates of side effects common with tetracycline antibiotics. J Drugs Dermatol. 2018;17(9):987-996.

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